Field of Invention
The present invention relates to at least one device, at least one system, at least one process and methods thereof to be used within the medical sciences, engineering, research and medical technologies, wherein the device is ingestible and untethered to perform functions of telemetry, obtaining and collecting samples, obtaining and storing information, transmitting information, perturbing an environment, sensing information and/or releasing/inserting/placing substances, devices, and/or sensors for use within or with the environment of a gut or gastrointestinal tract.
Description of the Related Art
Medicine has advanced in all major human body systems, such as cardiovascular, neurological, muscular and skeletal, but the intestinal tract still remains much of a mystery. Though there are instruments and devices which can be used for endoscopy/colonoscopy, there are sections of intestines that remain unexplored and are found incredibly difficult to collect and preserve samples there from. Even these upper and lower extremities, which can be viewed by camera and can only be treated for visible damage, such as polyps or ulcers. The roles bacteria play in the intestinal tract are generally not understood, except that there are “good” and “bad” bacteria. In fact, only a few of the estimated thousands of strains of bacteria are known, or have been identified, much less characterized and their roles determined. One known device is of a camera pill that can now be swallowed and pictures taken throughout the intestinal tract, but visible inspection does not address the scientific mysteries of diseases and their causes or cures.
In order to understand the causes of diseases and illnesses believed to be originating somewhere within the entire human intestinal tract, basic science and engineering data are necessary to analyze the biochemical, biological/physiological, and bioengineering processes taking place therein, along with the flora of microbes and the roles they play in the digestive and other involved processes. Currently, in most gut-related diseases, only the symptoms are being treated under a wide variety of named diseases, Celiac being an example, while the causes remain unknown. In order to advance the medical science, bioengineering and technology to the same levels of DNA, microbiology in general, etc., as in other anatomical systems, sufficient in-vivo data must be available to develop intrinsic models and identify physiological and biochemical processes, as opposed to superficial and grossly inferior statistical inference methods.
Specifically, what is not known within the human gut is a huge void in medical science and an aim of this invention, such as: the biochemical products existing for any specific diet are not known as a function of the gut length x; the biochemical reactions taking place along the gut are not known as a function of the gut length x; the microbes existing at any point within the gut anatomical system are generally unknown and unidentified; the byproducts of all microbes their toxins, exotoxins and endotoxins, and virulence factors and enzymes existing within the gut are likewise unknown, much less as a function of x; the aerobic/anaerobic distribution and associated conditions are vaguely known, but not as a function of x; the interaction of a) the normal biochemical reactions, b) the microbes, and c) the microbe byproducts are totally unknown, and believed to be a major source of several major diseases; the data necessary to identify and characterize physiological, biochemical or other bio-engineering processes, or construct any sort of a scientific, mathematical or engineering model of any component of the gastrointestinal system ranging from the stomach, duodenum, jejunum and ileum, through the colon are totally unavailable for healthy individuals as a function of x, much less for unhealthy individuals. Some 15 categories of bacteria have been broadly identified within the Phylogenic Tree as existing within major components of the gastrointestinal tract. The microbial flora distribution for the gastrointestinal tract has been broadly cataloged for major components of the system, and some general aerobe and anaerobe distributions and populations are broadly known for major components in healthy people, but not as a function of x, much less for people with diseases. More importantly, what about those new or previously undiscovered, or unidentified and uncharacterized strains that may be contributing to diseases. Thus, in general, bacteria strains and colonies and their populations, population densities, habitats, and characteristics and contributions to the digestive process are only very vaguely known in healthy individuals, and largely unknown in unhealthy individuals, much less as a function of x. 9. The characteristics of some bacteroides, individually, or in serial, or parallel, in conjunction with others and their independent diets and by-products in conjunction with the human digestive processes are generally unknown, much less as a function of x; and/or additional critical information needed includes the ratios of solids, liquids, and gases, as well as, their compositions, temperature, partial pressures, and other variables. These quantities and variables are totally unknown in the intestinal tract, for any specific diet, especially for unhealthy individuals, much less as a function of x.
There are many reasons why the human gut is largely unexplored, except for post mortem autopsies, which do not reflect much of the most important living dynamic phenomena and conditions. Meanwhile, medical treatments for symptoms of major diseases and illnesses, based upon hypothetical or worse, biased statistical data, form the basis of thousands of medications, and unnecessarily occupy valuable time of many medical professionals and clinics at a great cost to our economics, which could otherwise be focused on permanent cures based upon causes instead of symptoms, and based upon intrinsic models of fundamental biochemical processes.
The inaccessible regions of the most important anatomy of the gut, and the lack of technology to explore, discover, and experiment in an in vivo manner, and then administer medications and measure in vivo the immediate results, has constrained and obstructed beyond description throughout history the advance of medical science pertaining to the gut. A competent research effort investigating any animate or inanimate system should attempt to identify the fundamental multidisciplinary scientific principles of science and engineering upon which the system is based and functions, and then develop quantitative measures of those principles. The inaccessibility of the gut, and heretofore lack of technology, has resulted in speculation and statistical correlation of symptoms from a distance throughout history as a means of researching the gut. The need for in vivo technology became immediately apparent. Eventually the various concepts were condensed into three basic tools, Capsules A, B and C, and additional supporting technology and infrastructure, that when ultimately developed and implemented as a system, should address the immediate need to serve a creditable scientific and engineering systems approach to introduce gut in vivo technology.
The applicant has advanced the state of the art technology for discovery of microbes and their byproducts that contribute to the normal and abnormal human, or other animal, digestive processes and the consequential processes introduced by autoimmune system responses. In summary, these contributions are herein referenced in U.S. Pat. Nos. 8,491,495, 8,915,863, 8,926,526 and 9,215,997. These referenced patents serve the purposes, respectively, of: '495) in Capsule A, profiling the entire GI tract microbes in each patient simultaneously at each point in space and time within the gut upon external command along with the chemical substances created as byproducts from the existing populations of microbes at said points in space and time, including the constituent normal food products as at some points referred to as chyme, which include secreted acid and enzymes; '863) in Capsule B, conducting all phases of research on all aspects of the normal and abnormal digestive process, and processes that lead to or constitute diseases of which some 53 major human diseases have been referenced as having their origin in the gut; '526) in Capsule C, a patient diagnostic and treatment capsule, wherein sampling of all sorts and perturbing of the gut is performed to diagnose patient conditions, and wherein substances can be deployed to treat specific ascertained conditions, and post treatment results can be measured, are specifically claimed; and '997) incorporates the various methodologies, processes, protocols and broad techniques employed to render a new human healthcare system when all 4 patented technologies are utilized appropriately in patient diagnostics, treatment and research applications. Substances are all-inclusive of any gaseous, liquid, solid or gel state, and of any physical, chemical, or other nature. Deployment of substances may include small objects of micro shape and size to perturb the autoimmune system, including all possible combinations, such as, “seeds” for prostate cancer treatment, which at the molecular and cellular levels may induce responses from the autoimmune system it may recognize as a threat.
This invention is intended to provide this and more enabling science and engineering data and information that can lead to revolutionary improvements in general health care. This invention is intended to provide a device, process and method thereof to be used for at least one of collection of samples, obtaining information, or releasing materials or objects for diagnostic and research purposes within the medical and science fields pertaining to the path of the gastrointestinal tract and surrounding paths of travel. Embedded in all of this is to isolate, condense, shrink, and constrain the research defined “system” in order to reduce the huge number of variables in any animate system to a tractable number, using extreme precision and resolution along with extreme protocols. Gut variables number over 6,000 due to the 3,000 plus bacteria strains and 3,000 minimum byproducts as their populations vary from 107 cells/gram in small intestine to 1011 in colon. This new technology is designed to: a) compress longitudinal studies/research from 20 years or more to weeks or months in some cases, and in other cases from months to hours, days or weeks. b) reduce the numbers of variables by 3 or 4 orders of magnitude (104), c) increase sampling precision and resolution by 4 or 5 orders of magnitude (105), d) expedite test cycles to 2/week compared to months to enhance repeatability, expedite discovery, reduce extraneous variables, and e) allow quick trial and immediate evaluation of critically important variables, such as diet and medication effects, among several other improvements compared to current methodologies.